A Study of DER 45-EV Gel to Treat Rosacea (SGTDER45EV)

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Range Study of DER 45 EV Gel, 1% and 5%, and Vehicle Gel in the Treatment of Rosacea

To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: DER 45 EV; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33175
      • FXM Research Corp
    • Miami, Florida, United States, 33140
      • Baumann Cosmetic & Research Institute
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Augusta Centre for Dermatology and Skin
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch, Inc
    • College Station, Texas, United States, 77840
      • J & S Studies, Inc
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin and Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females, 18 years of age or older
• Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)
• Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA
• Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study

Exclusion Criteria:

• Subjects who are pregnant, breast feeding, or planning a pregnancy during the study
• Allergy or sensitivity to ingredients in test product
• Any dermatological conditions of the face that may interfere with study evaluations
• Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DER 45 EV Gel, 1%; DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks	Drug: DER 45 EV; Topical application to face for 12 weeks
Placebo Comparator: Vehicle; Placebo Gel applied topically once a day for 12 weeks	Drug: Vehicle; Topical application to face for 12 weeks
Experimental: DER 45 EV Gel, 5%; DER 45 EV Gel, 5% applied topically once a day for 12 weeks	Drug: DER 45 EV; Topical application to face for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment (IGA) Improvement From Baseline	The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).	Baseline to Week 12 / end of treatment
Change in Inflammatory Lesion Counts From Baseline	The LS mean changes from Baseline in inflammatory lesion count at Week 12.	Baseline to Week 12 / end of treatment

Collaborators and Investigators

• Sponsor: Sol-Gel Technologies, Ltd.
• Investigators: Study Director: Ofra Levy-Hacham, PhD, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 16, 2009
• First Posted (Estimate): July 17, 2009

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: December 31, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: SGT DER 45 EV 09